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SMC2888
|
08/12/2025
|
trastuzumab deruxtecan (Enhertu)
|
Non submission
|
Monotherapy for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low or HER2-ultralow breast cancer who have received at least one endocrine therapy in the metastatic setting and who are not considered suitable for endocrine therapy as the next line of treatment
|
|
|
SMC2854
|
11/08/2025
|
trastuzumab deruxtecan (Enhertu)
|
Non submission
|
For the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumours who have received prior treatment or who have no satisfactory alternative treatment options.
|
|
|
SMC2706
|
12/08/2024
|
trastuzumab deruxtecan (Enhertu)
|
Non submission
|
As monotherapy is indicated for the treatment of adult patients with advanced NSCLC whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.
|
|
|
SMC2693
|
08/07/2024
|
trastuzumab deruxtecan (Enhertu)
|
Non submission
|
As monotherapy for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.
|
|
|
SMC2608
|
11/12/2023
|
trastuzumab deruxtecan (Enhertu)
|
Full
|
As monotherapy for the treatment of adult patients with unresectable or metastatic HER2‑low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.
|
|
|
SMC2545
|
10/04/2023
|
trastuzumab deruxtecan (Enhertu)
|
Full
|
As monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received one or more prior anti HER2 based regimens.
|
|
|
SMC2388
|
17/01/2022
|
trastuzumab deruxtecan (Enhertu)
|
Full
|
As monotherapy for the treatment of adult patients with unresectable or metastatic HER2 positive (HER2+) breast cancer who have received two or more prior anti-HER2-based regimens.
|
|